A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus

October 17, 2022 updated by: InteKrin Therapeutics, Inc.

A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus

The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States
        • Whittier Diabetes Institute
      • Los Angeles, California, United States
        • National Research Institute
      • Los Angeles, California, United States
        • Charles R. Drew University
      • Santa Ana, California, United States
        • Lovelace Research Institute
    • Florida
      • Miami, Florida, United States
        • University of Miami
    • Indiana
      • Evansville, Indiana, United States
        • GFI Research Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Joslin Diabetes Center
    • Minnesota
      • Edina, Minnesota, United States
        • Radiant Research
    • Missouri
      • Saint Louis, Missouri, United States
        • Radiant Research
      • Saint Louis, Missouri, United States
        • St Louis Center For Clinical Research
    • New York
      • Buffalo, New York, United States
        • Kaleida Health Diabetes Center
      • Rochester, New York, United States
        • Rochester Clinical Research
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States
        • Radiant Research
    • South Carolina
      • Anderson, South Carolina, United States
        • Radiant Research
    • Texas
      • Dallas, Texas, United States
        • Baylor University Endocrine Center
      • Dallas, Texas, United States
        • Dallas Diabetes and Endocrine Research Center
      • Dallas, Texas, United States
        • Endocrine Associates Of Dallas
      • San Antonio, Texas, United States
        • Diabetes and Grandular Disease Clinic and Reseach Center
    • Utah
      • Ogden, Utah, United States
        • Endocrine Research Specialists
    • Virginia
      • Salem, Virginia, United States
        • Salem VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment
  • Fasting Plasma Glucose between 126 and 240 mg/dL
  • Hemoglobin-A1c (HbA1c) between 6.8% and 10.0%
  • Fasting C-peptide > 0.8 ng/mL

Exclusion Criteria:

  • Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening
  • Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone
  • BMI > 42 kg/m2
  • Presence of any diabetic complications requiring chronic therapy
  • Presence or history of any form of hepatic disease
  • Serum creatinine > 1.8 mg/dL
  • History of cardiac arrhythmias or abnormal cardiac electrophysiology
  • Any reason that, in the Investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T0903131 Besylate
1.0 mg
Drug: T0903131 Besylate
Once daily, oral
Other Names:
  • INT131 Besylate
Experimental: T0903131 Besylate (higher dose)
10.0 mg
Drug: T0903131 Besylate
Once daily, oral
Other Names:
  • INT131 Besylate
Placebo Comparator: Placebo
Once daily, oral
Drug: Placebo
Once daily, oral

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InteKrin Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-131-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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